Usual Adult Dose for Pain

Initial dose: 10 mg IV, IM, or subcutaneous every 3 to 6 hours as needed

OPIOID NON-TOLERANT:
Maximum single dose: 20 mg
Maximum daily dose: 160 mg

Comments:

• Usual adult dose is based on a 70 kg individual; dosage should be adjusted according to the severity of pain, physical status, and concomitant medications.
• Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and with each dose increase.
• Because of the risks of addiction, abuse, and misuse, reserve use to patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia or are not expected to provide adequate analgesia.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Adult Dose for Anesthesia

Supplement to balanced anesthesia:
Induction dose: 0.3 to 3 mg/kg IV over 10 to 15 minutes
Maintenance dose: 0.25 to 0.5 mg/kg in single IV administrations as required

Comments:

• This drug should be administered as a supplement to general anesthesia by persons specifically trained in the use of IV anesthetics and management of the respiratory effects of potent opioids; naloxone, resuscitative and intubation equipment and oxygen should be readily available.

Use: As a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

Renal Dose Adjustments

Dose adjustments may be required; however, no specific guidelines have been suggested; lower doses should be considered.

Liver Dose Adjustments

Dose adjustments may be required; however, no specific guidelines have been suggested; lower doses should be considered.

Dose Adjustments

Elderly: Use with caution; generally initiate at the low end of the dosing range

Do not abruptly discontinue in physically dependent patients:

• Taper gradually by 25% to 50% every 2 to 4 days while monitoring for signs and symptoms of withdrawal
• If signs and symptoms of withdrawal appear, raise the dose to previous level and taper more slowly

Precautions

US BOXED WARNINGS:

• LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use, particularly when used concomitantly with other opioids or central nervous system depressants. Monitor for respiratory depression, especially during initiation of therapy or following a dose increase.
• RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant use for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Naloxone, resuscitative and intubation equipment, and oxygen should be readily available when used for balanced anesthesia

Storage requirements:

• Protect from excessive light; keep ampules in tray until time of use

General:

• Due to the risk of addiction, abuse, and misuse with opioids, even at recommended doses, use of this drug for pain management should be reserved for those patients for whom alternative treatment options (non-opioid analgesics) are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient pain management; the lowest effective dose should be used for the shortest duration consistent with individual patient treatment goals.
• Proper dosing and titration are essential to reduce the risk of respiratory depression.

Monitoring:

• Cardiovascular: Monitor for signs of hypotension upon initiating therapy and following dose increases, especially those whose blood pressure is compromised
• Respiratory: Monitor for respiratory depression, especially within the first 24 to 72 hours of initiation and with dose increases.
• Gastrointestinal: Monitor for constipation and decreased bowel motility in post-operative patients.
• General: Monitor routinely for maintenance of pain control and incidence of adverse reactions.
• Psychiatric: Patients should be monitored for the development of addiction, abuse, or misuse.

Patient advice:

• Patients should understand that this drug, even when taken as recommended can result in addiction, abuse, and misuse; instruct patients not to share their drug with others and protect from theft or misuse.
• Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest; patients should be advised to avoid alcoholic beverages, or respiratory depressant medications while on treatment.
• This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery during therapy.
• Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
• Patients should be instructed in proper disposal.